Study Details

Open

Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer

To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival (EFS) compared to standard-of-care surgery in resectable stage III/IV cutaneous squamous cell carcinoma (CSCC)

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

If you decide to take part in this study, before you begin, your doctor will review the results of our exams, tests, and procedures.This helps your doctor decide if it is safe for you to take part in the study. If you join the study, you will have more exams, tests, and procedures to closely monitor your safety and health. Most of these are included in the usual care you would get even If you were not in a study. Some exams, tests, and procedures are a necessary part of the research study, but would not be included in usual care. Additionally, all participants will be asked to fill out two forms with questions about your ability to swallow, your physical well-being, and your emotional well-being. Researchers will use this information to learn more about how cancer and cancer treatment affects people.

In-person visits:
10 plus

Phone or online visits:
5 -8

Total length of participation:
5 years

Looking for Specific Volunteers

Able to participate:

Invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC.
Previously untreated or recurrent CSCC
ECOG Performance Status of 0-2
Tumor must be resectable with curative intent

Not eligible if:

Women who are pregnant or of child bearing potential and sexually active men unable to use acceptable forms of contraception
Prior allergic reaction to any of the study agents
No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
No prior systemic therapy for the study cancer.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Comprehensive Cancer Center Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Sid Sheth
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck)

IRB Number

25-1896

ClinicalTrials.gov

NCT06568172